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Leo puts target on Dupixent in US as FDA clears tralokinumab

pharmaphorum

IL-13 inhibitor tralokinumab has been cleared by the US regulator as Adbry as a treatment for moderate-to-severe atopic dermatitis in adults who can’t control symptoms using topical prescription therapies. It continues to grow strongly with Sanofi reporting a 53% rise in sales to more than $4.1 billion in the same year.

Sales 109
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FDA clears Incyte’s Opzelura as first vitiligo therapy

pharmaphorum

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. The company is gunning for sales in atopic dermatitis alone of $1.5 million people in the US.

Sales 98
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Novartis probed by Swiss authorities over ‘unlawful’ patent use

pharmaphorum

.” The Swiss Competition Commission (COMCO) arrived unexpectedly at Novartis at dawn on Tuesday morning, to gather information on an unidentified dermatology drug, as part of a wider investigation into the drugmaker by the European Commission.

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FDA grants speedy review to Dupixent rare skin disease

pharmaphorum

The US regulator has granted Dupixent (dupilumab) a six-month priority review in PN and is due to deliver a verdict by 30 September, offering patients hope of a first-approved therapy for the highly-debilitating disease. billion) a year and some analysts predicting levels could go as high as $12.5

Sales 115
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Scepticism in press over Kintor’s COVID-19 US drug trial

pharmaphorum

Proxalutamide is not approved or available for sale and the Brazilian study has not been peer-reviewed or published. Kintor is in talks with the Brazilian health regulator Anvisa about a further trials. Kintor is in talks with the Brazilian health regulator Anvisa about a further trials.

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FDA turns down Amryt’s epidermolysis bullosa drug

pharmaphorum

Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare and debilitating skin disease epidermolysis bullosa (EB).

Drugs 98
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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. billion in pharmaceutical sales from 2021. In contrast, several drugs experienced sale declines, such as Remicade (infliximab), an old immunology medication that continues to decline due to the rise of biosimilars since 2016.

Sales 98